SOP Number:
(Assigned by AACUC)
Version 6/2015
TEXAS A&M AGRILIFE RESEARCH
AGRICULTURE ANIMAL CARE AND USE COMMITTEE
RESEARCH/TEACHING PROPOSALS INVOLVING ANIMAL SUBJECTS
STANDARD OPERATING PROCEDURES (SOP) FORM
Research investigators and class instructors are entrusted with an essential role in assuring the humane care and
use of animals. In activities you conduct or that are conducted under your supervision, you have a direct and
continuing responsibility to ensure that animals are adequately cared for and used in a humane fashion.
Investigators and instructors must ensure that discomfort, pain or injury to the animals is avoided or minimized,
consistent with sound experimental/teaching design; that no more animals are used than are necessary to reach
sound scientific conclusions or to teach the class; and that, when appropriate, animals are painlessly sacrificed in
accordance with methods of euthanasia approved by the Panel on Euthanasia of the American Veterinary Medical
Association.
ATTENTION! This is a newly revised form. Please type responses in the pre-formatted boxes provided. All
animal procedures should be described on this form - no attachments. To place a checkmark in any of the “yes”
or “no” boxes: double-click box, change default value to checked and select OK. Please submit this form to the
AACUC in Microsoft Word format. If you have problems with this form, please let us know by sending an email
to aganimal@ag.tamu.edu.
Complete all information below
Investigator/Instructor:
Department:
Project/Class Title:
Is this SOP intended for continued work on a funded grant? (i.e., was SOP approved before grant?)
No
Yes - Previous SOP #
Is this SOP intended to replace another approved SOP?
No
Yes - Previous SOP #
ANIMAL USAGE (pertains to project design, not to species):
Experiments involving food or fiber research or production (AACUC)
Experiments of a biomedical nature (AACUC)
Client-Owned Animals (CVM CRRC, AACUC)
Experiment Station (PHS or USDA Regulated Species, AACUC)
Page 1
SOP Number:
(Assigned by AACUC)
Version 6/2015
FOR COMMITTEE ACTION ONLY
Approved by AACUC on
(DATE)
John Walker, Chair
Agriculture Animal Care and Use Committee
Texas A&M AgriLife Research
Page 2
SOP Number:
(Assigned by AACUC)
Version 6/2015
INVESTIGATOR’S/INSTRUCTOR’S ASSURANCE
Texas A&M AgriLife Research recognizes the importance of the use of animals in its research, teaching, and testing
programs, and is committed to maintaining high standards for the care and use of animals in research, teaching, and testing.
Texas A&M AgriLife Research has adopted the Guide for the Care and Use of Agricultural Animals in Research and
Teaching and complies with all applicable portions of the Animal Welfare Act, and all other federal, state, and local laws
which impact the care and use of animals in agricultural and field research. A&M AgriLife investigators, teachers, staff, and
students accept responsibility for determining that research, teaching, and testing involving the use of animals fulfills these
principles, policies, and regulations. To assure compliance:
•APPROVAL OF AUPS. Approval of an Animal Use Protocol (AUP), by the Agriculture Animal Care and Use Committee, is required
for all vertebrate animal use. All vertebrate animals must be covered by an active AUP, even after termination of a project.
•DURATION OF APPROVAL. AUPs are approved for a three-year period and require two annual reviews. The first annual and second
annual reviews are due on the anniversary of the date the AACUC approved the protocol. A new AUP approval is required for
continuation beyond the three-year period.
•AMENDMENTS TO AUPS. Any proposed change in personnel, species usage, animal procedures, anesthesia, post-operative care, or
biohazard procedures to the animal portion of a study must be reported in writing to the AACUC for approval. Committee approval of the
proposed amendment is required prior to proceeding with the revised animal procedures.
•INFECTIOUS BIOHAZARDS, RECOMBINANT DNA. All animal research projects involving infectious biohazards and recombinant
DNA, including procedures such as introduction of recombinant organisms into animals and generation of transgenic or knockout animals,
must be registered and approved by the TAMU Institutional Biosafety Committee (IBC).
•TRAINING OF PERSONNEL. All personnel working with animals, from the animal care staff to the persons doing the
experiments/teaching must be qualified by training and/or experience to do so. On-line training is available through the CITI website at
www.citiprogram.org. All personnel working with animals must be informed of the TAMU Occupational Health and Safety Program for
Animal Care and Use Facilities, and have the opportunity to participate fully in the program.
•PROGRAM EVALUATIONS. All approved animal housing locations will be inspected twice annually. Unannounced inspections and
observations of animal quarters and/or experimental or teaching procedures may be performed by the attending veterinary staff. Where
procedures are causing severe distress to an animal and the pain cannot be relieved, veterinarians are authorized to humanely destroy that
animal. Institutional Veterinarians will make a concerted effort to discuss these situations with investigators/instructors prior to initiating
such action. The Committee is authorized to suspend research/teaching which does not conform to approved procedures outlined in the
AUP.
Signature certifies that the Principal Investigator/Instructor:
1. Understands the requirements of the Guide for the Care and Use of Agricultural Animals in Research and Teaching,
applicable portions of the Animal Welfare Regulations (Animal Welfare Act), and the Institution's policies
governing the use of vertebrate animals for research, testing, teaching, or demonstration purposes.
2. Will conduct the project/course in full compliance with the aforementioned requirements.
3. Will assure that personnel are appropriately trained and will conduct all procedures as described in this AUP.
4. Assures that this AUP accurately reflects the research/teaching described in any accompanying grant
proposal.
5. Assures that the proposed work does not unnecessarily duplicate previous experiments.
6. Understands that work with animals is limited specifically to what is approved in this document.
Typed Name of Investigator/Instructor
Signature of Principal Investigator/Instructor
Date
Typed Name of Graduate Student (if applicable)
Signature of Graduate Student
Date
Page 3
SOP Number:
(Assigned by AACUC)
Version 6/2015
INVESTIGATORS MAY DESIGNATE UP TO BUT NO MORE THAN TWO PERSONS TO
ACT ON THEIR BEHALF TO REVISE AND AMEND PROTOCOLS AND SUBMIT
TRANSFERS AND ANNUAL REVIEWS.
THE INVESTIGATOR REMAINS SOLELY
RESPONSIBLE FOR THE CONTENT OF THE AUP AND THE CONDUCT OF THE ANIMAL
WORK.
Designee Name(s):
Certification of ALL Participants in Research/Teaching Procedures
(Anyone whose name appears in the SOP)
Signature certifies that the participant:
1. Understands the requirements of the Public Health Service Policy for the Humane Care and Use of
Laboratory Animals, applicable portions of the Animal Welfare Regulations (Animal Welfare Act),
and the Institution’s policies governing the use of vertebrate animals for research, testing, teaching
and for demonstration purposes.
2. Will conduct the project/class in full compliance with the aforementioned requirements.
3. Understands his/her role in the SOP, and agrees to perform it and assures that he/she has the
appropriate skills to do so.
4. Further understands that work with animals is limited specifically to what is approved in this
document.
Typed Name of Participant
Signature
Please add as many lines as necessary.
Page 4
Date
SOP Number:
(Assigned by AACUC)
Version 6/2015
Instructions to Investigators: All questions must be answered even if not applicable (N/A). This form must be
type written. PLEASE USE AS MUCH SPACE AS NECESSARY TO COMPLETELY ANSWER EACH
QUESTION.
SECTION I. PROJECT SCOPE
A.
Investigator/Instructor:
Department:
Address:
Work Phone:
Qualifications:
E-Mail:
Emergency Phone:
B. Title of Project/Class:
Funding Source:
(e.g., NIH, USDA, AHA, Teaching, Internal)
C. Project Animal Care Personnel: (Who is to be contacted in case of an animal emergency?)
Name:
E-Mail:
Work Phone:
Emergency Phone:
Qualifications:
Name:
Work Phone:
Qualifications:
E-Mail:
Emergency Phone:
Name:
Work Phone:
Qualifications:
E-Mail:
Emergency Phone:
D. Purpose (Please provide a brief statement, in LAY TERMINOLOGY, understandable by someone with a
high school education, with no acronyms or scientific jargon, describing the animals covered by this
Standard Operating Procedure and how they contribute to your research or management.)
E. Assessment of Pain and Distress (For more information, refer to http://awic.nal.usda.gov/alternatives)
All animal procedures described in this Standard Operating Procedure are commercial husbandry
practices routinely carried out on agricultural animals that may cause temporary discomfort or pain as
described in the “Guide for the Care and Use of Agricultural Animals in Research and Teaching, Third
edition” (2010). These standard agricultural practices need not necessarily be described separately for
each study, experiment, or demonstration, but are acceptable as written operating procedures provided
that the practices 1) are warranted to sustain the long-term welfare of the animal and(or) the animal’s
caretakers or handlers; 2) are performed by or under the direct supervision of capable, trained, and
experienced personnel; and 3) are performed with precautions taken to reduce pain, stress, and infection?
If the procedures described in this SOP meet the criteria described above in I.E., proceed to question
I.E.3. below.
Page 5
SOP Number:
(Assigned by AACUC)
Version 6/2015
1. Does the project/class exercise involve the use of painful procedures or paralytic drugs without the
benefit of anesthetics or analgesics
Yes
No
IF YES, justify why anesthetics/analgesics are inappropriate for your experiments.
2. Could the procedures or outcome of this project/class cause more than slight or momentary pain or
distress to animal subjects? (Be advised that the USDA has ruled that any surgical procedure has
the potential for pain and/or distress.)
No
Yes (COMPLETE THE SECTION ON ALTERNATIVES BELOW.)
A.
As described in Section III.D.I., any potential pain or distress to these procedures will be
relieved through use of anesthetics and analgesics and alternatives to these procedures are not
available. (COMPLETE THE SECTION ON ALTERNATIVES BELOW.)
B.
But as described in Section III.D.I., anesthetics and analgesics are inappropriate for these
procedures. Alternatives to these procedures are not available. (COMPLETE THE SECTION ON
ALTERNATIVES BELOW.)
Describe the methods and sources you used to determine that alternatives to these procedures are not
available. These might include computerized database searches (BIOSYS, Current Contents,
Medline, PubMed, Agricola). Be advised that database searches are not the only source of
alternatives.
Databases searched:
Dates searched (inclusive):
Keywords:
3. Is there a possibility of any illness in the animals as a result of experimental/teaching procedures?
Please include any clinically significant side effects that may occur in genetically modified animals.
No
Yes (If yes, answer a-d below.)
a. Describe those effects and explain at what point and by what objective criteria (such as clinical
condition) the animals may be euthanized or permanently removed from the study/class.
b. Describe the frequency per day that you or your staff will observe the animals after treatment
administration.
c. Describe the monitoring and recording procedures for determining physiological or behavioral
abnormalities.
d. State what measures will be taken to minimize or alleviate problems associated with
experimental/teaching procedures.
Page 6
SOP Number:
(Assigned by AACUC)
Version 6/2015
SECTION II. SPECIES AND BEST ESTIMATE OF NUMBER OF ANIMALS
List the total number of animals used, by species, and/or class of livestock within a species for the
duration of the project. (You can provide a narrative in the space below or use the tables.)
TOTAL NUMBER FOR
SPECIES
DURATION OF AUP
If the project involves breeding animals, please also complete the table below. These numbers, for the
duration of the project, should be included in the overall total above.
SPECIES
TOTAL NUMBER OF
ADULT BREEDERS
NEEDED
ESTIMATED TOTAL
NUMBER OF OFFSPRING
TO BE PRODUCED
SECTION III. ANIMAL PROCUREMENT
A. Biosafety (Newly acquired animals may cause health risks to resident animals. Describe precautions
such as quarantine and acclimation periods should be taken to insure that newly acquired animals are
healthy and will not transmit diseases to resident animals.)
B. Where will you obtain the animals? (If wild-caught by you, please describe applicable permits,
method of capture and evaluation of health risks to personnel. Please provide a copy of permit
approvals (contact the AACUC committee chair if this presents a problem). Complete Field Studies
Form, Attachment 4, for wild capture studies.)
C. Animal Transfer (check all that apply)
Internal to another AUP/SOP
External (outside agency, slaughter, adoption, etc.) If adopting animals to private homes, please
provide your laboratory procedures and guidelines. Transfer to a private destination requires
prior approval. Assure appropriate drug withdrawal times if applicable.
SECTION IV. ANIMAL HEALTH PROGRAM
A.
Preventative Medicine
1. Vaccination Programs
2.
Internal/External Parasite Control
Page 7
SOP Number:
B.
C.
(Assigned by AACUC)
Version 6/2015
Surgical Procedures
1. Description (e.g., castration, dehorning, etc.)
2.
Recovery
3.
Potential Post-operative Complications
4.
Post-operative Medications
Medication
Dose
Route
Frequency
Veterinary Care
1. The following veterinarians provide services as necessary and advise on animal health:
Name
Address
Phone
2.
Routine veterinary treatment for common diseases by Texas A&M AgriLife Research Station staff:
D.
Residue Avoidance
E.
Medical Records (Please describe types of medical records kept for individual animals.)
SECTION V. REPRODUCTIVE MANAGEMENT (Please describe types of breeding, e.g., natural, a.i.,
pregnancy determination if done and other routine management activities associated with reproduction.)
SECTION VI. ENVIRONMENTAL MANAGEMENT
A.
Housing
1. Where will you house the animals (i.e., pastures, feedlot, pens and caging systems…)?
2.
B.
Is the facility AACUC approved?
Yes
No (Please contact the AACUC office at (325) 657-7333 to schedule a
facility evaluation.)
Range and Pasture Systems
1. Water
Page 8
SOP Number:
C.
(Assigned by AACUC)
Version 6/2015
2.
Assessment of supplementation requirement
3.
Fencing
4.
Social environment
Feedlot and Confinement Systems
1. Space allocations
2.
Environmental control
3.
Cleaning/sanitation methods
4.
Fencing
5.
Floor surface
6.
Ventilation
7.
Social environment
SECTION VII. NUTRITIONAL MANAGEMENT
A.
Feedstuffs (Type and source of feedstuffs, e.g., pasture, harvested forages, concentrates, etc.):
B.
Nutritional Status:
SECTION VIII. ANIMAL IDENTIFICATION AND INVENTORY
Page 9
SOP Number:
(Assigned by AACUC)
Version 6/2015
SECTION IX. ENVIRONMENTAL ENRICHMENT (When social interactions are not available or
where the animals’ physical environment lacks complexity, how will the social or physical environment be
enriched?)
SECTION X. ANIMAL HANDLING AND TRANSPORT (Include routine procedures such as weighing,
shearing, weaning, etc.)
SECTION XI. EMERGENCY PROCEDURES
A. Sick, Injured or Down Animals
B. Animal Escape
C. Injured Personnel and Notification Procedures (All participants listed on this SOP must be enrolled in
the TAMUS Occupational Health and Safety Program and must have passed the Collaborative
Institutional Training Initiative online course “Working with the IACUC.”)
D. Disaster plans (In the event of weather or other natural disasters, what are the contingency plans for
insuring animal well-being?)
E. Euthanasia (Even when euthanasia is not an integral part of the SOP, please provide an adequate
protocol for euthanasia in case there is an unexpected event. If drugs are used describe agent, dose and
route. Include procedures for determination of death for all methods. For more information on this
procedure, please refer to the AVMA Guidelines for the Euthanasia of Animals (RCB website, bullet #2 listed under “Other Resources”) at https://www.avma.org/KB/Policies/Pages/EuthanasiaGuidelines.aspx?utm_source=prettyurl&utm_medium=web&utm_campaign=redirect&utm_keyword=iss
ue-animal_welfare-euthanasia-pdf. )
Page 10
SOP Number:
(Assigned by AACUC)
Version 6/2015
ATTACHMENT I
FIELD STUDIES
Assurance of Health and Safety
of Personnel Performing Field Studies Involving Animals
Instructions to Investigator/Instructor: The purpose of this Attachment is to assure that consideration is given to
safety and well-being of university personnel participating in field studies. It is a part of the institutional
compliance with the Guide for the Care and Use of Laboratory Animals and the Guide for the Care and Use of
Agricultural Animals in Agricultural Research and Teaching.
I hereby certify that there is a program in place to assure the safety of personnel participating in this
proposed work. The program involves hazard identification and risk assessment, appropriate equipment
for safe conditions for the work, personnel training and education, and preventive medical oversight. It
includes an emergency plan which covers the following:
A mechanism to evacuate personnel, if necessary, in a timely fashion,
A permanent and dependable system such as telephone, cellular phone, or radio for continuous
emergency communication capability,
A local contact for health and safety emergencies,
Necessary medical coverage (insurance),
Appropriate individual medical preparedness,
Vaccine and preventive medical precautions as deemed necessary by a physician,
Adequate supplies of prescription drugs/devices,
First Aid and Cardiopulmonary Resuscitation skills,
Method to assure contact of University Human Resources Department in the event of accident/injury,
Credentials and/or training in safety procedures necessary for carrying out the work as determined by the
Principal Investigator.
Signature of Investigator/Instructor
(Signature does not imply transfer of liability)
Date
Page 11